News about GMP/cGMP


Amendment of Delegated Regulation (EU) on Safety Features

Amendment of Delegated Regulation (EU) on Safety Features

Already in March last year, an adaption of the Delegated Regulation (EU) 2016/161 on safety features allowed a temporary derogation of the obligation for wholesalers to deactivate the individual identifier (IE) of medicinal products exported to the UK - as a third country (we reported). This exemption was granted for the year 2021.

The derogation has now been extended for another three years until 31 December 2024. With this step, the supply of medicines to Cyprus, Ireland, Northern Ireland, and Malta should be guaranteed. Furthermore, it is intended to give all parties involved sufficient time to adjust their supply chains, accordingly.

An alert system has been introduced to monitor and prevent abusive access. This is to ensure, in view of the limited monitoring possibilities, that no verification of a medicine destined for these countries takes place outside the European Economic Area.

Please find more information here.


EC: Delegated Regulation (EU) of 17.12.2021

EC: Delegated Regulation (EU) 2016/161